Mobile Outpatient Cardiac Telemetry (e.g. CardioNet)

National Medical Policy
Subject:
Mobile Outpatient Cardiac Telemetry
(e.g. CardioNet, Nuvant )
Policy Number:
NMP161
Effective Date*: July 2004
Updated:
May 2014
This National Medical Policy is subject to the terms in the
IMPORTANT NOTICE
at the end of this document
For Medicaid Plans: Please refer to the appropriate Medicaid Manuals for
coverage guidelines prior to applying Health Net Medical Policies
The Centers for Medicare & Medicaid Services (CMS)
For Medicare Advantage members please refer to the following for coverage
guidelines first:
Use
X
National Coverage Determination
(NCD)
Reference/Website Link
Electrocardiographic Services:
http://www.cms.gov/medicare-coveragedatabase/search/advanced-search.aspx
National Coverage Manual Citation
Local Coverage Determination
(LCD)*
X
Article (Local)*
Other
ECG-based Signal Analysis Technologies:
http://www.cms.gov/medicare-coveragedatabase/details/technology-assessmentsdetails.aspx?TAId=73&CoverageSelection=Natio
nal&KeyWord=arrhythmia&KeyWordLookUp=Titl
e&KeyWordSearchType=And&bc=gAAAABAAAAA
A&
Systematic Review of ECG-based Signal Analysis
Technologies for Evaluating Patients With Acute
Coronary Syndrome:
Mobile Outpatient Cardiac Telemetry (CardioNet) May 14
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http://www.cms.gov/medicare-coveragedatabase/details/technology-assessmentsdetails.aspx?TAId=83&CoverageSelection=Natio
nal&KeyWord=arrhythmia&KeyWordLookUp=Titl
e&KeyWordSearchType=And&bc=gAAAABAAAAA
A&
None
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Current Policy Statement (Refer also to Health Net Medical Policy,
Implantable Cardiac Event Monitors)
Health Net, Inc. considers Mobile Outpatient Cardiac Telemetry (MCOT) medically
necessary in a very select patient population who meet all of the following:
1. Patient has symptoms suggestive of an underlying arrhythmia, such as:
a. Pre-syncope and syncope of unknown etiology
b. Dizziness or lightheadedness
c. Stroke or transient cerebral ischemia, possibly secondary to atrial
fibrillation
2. A Holter monitor does not detect any arrhythmia during a 24-hour period, or
symptoms occur infrequently (less frequently than daily) such that the
arrhythmia is unlikely to be diagnosed by Holter monitoring.
3. A cardiac event monitor (i.e., external loop recorder) for 30 continuous days has
failed to reveal an underlying arrhythmia as the cause of the symptoms; or the
episodes do not last long enough to activate the monitor reliably; or the
individual is unable to manage the technical requirements of a standard loop
recorder
4. It is anticipated that the results of this service would provide diagnostic and
treatment information
5. Patients who are at low risk of developing primary ventricular fibrillation or
sustained ventricular tachycardia.
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6. Symptomatic patients who require monitoring for non life-threatening
arrhythmias, such as atrial fibrillation, other supra-ventricular arrhythmias,
evaluation of various brady-arrhythmias and intermittent bundle branch block,
such as any of the following:

Patients recovering from coronary artery bypass graft surgery or valve
replacement surgery who have had documented symptomatic atrial
arrhythmias

Patients with symptomatic underlying structural heart disease

Patients with no structural heart disease but who have recurrent severe
symptoms (i.e., recurrent syncope), in whom all testing (e.g. cardiac
catheterization, EPS, tilt table testing) is negative and an implantable
event recorder is contemplated

Patients with uncontrolled atrial fibrillation post-pneumonectomy
Investigational
Health Net Inc. considers the Zio Patch investigational as a type of mobile
outpatient cardiac telemetry (MCOT). Although studies are currently being done,
additional, larger, peer-reviewed and comparative studies with devices currently
being used to assess cardiac arrhythmias are necessary to determine if Zio Patch is
equal to or superior in clinical outcomes.
Not Medically Necessary
Health Net Inc. considers Mobile Outpatient Cardiac Telemetry (MCOT) not
medically necessary for any of the following:
1. Patients who have a history of sustained ventricular tachycardia or a
documented occurrence of ventricular fibrillation
2. Patients who the attending physician thinks will be at risk for ventricular
tachycardia or ventricular fibrillation as indicated by the following:









Family history with a high likelihood of life-threatening arrhythmias
Mild to moderate symptoms (i.e., palpitations or weakness)
A measured ejection fraction of less than 30% with a widened QRS
A measured ejection fraction of less than 35% with complex ventricular
ectopic activity (> 10 PVCs per hour or repetitive PVCs)
Unstable angina defined as chest pain at rest, a new onset of angina, or
a change in existing patterns of angina
Patients with a recent (< 3 months) myocardial infarction (MI)
Patients who are candidates for or have had recent heart valve surgery
Patients with moderate to severe symptoms (i.e., syncope or near
syncope) with underlying structural disease and a high likelihood of
serious arrhythmias
Patients who would be more appropriately cared for in a hospital setting
This system is also NOT indicated for use as a screening tool.
Codes Related To This Policy
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NOTE:
The codes listed in this policy are for reference purposes only. Listing of a code in
this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and
medical necessity criteria. This list of codes may not be all inclusive.
On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and
inpatient procedures will be replaced by ICD-10 code sets. Health Net National
Medical Policies will now include the preliminary ICD-10 codes in preparation for this
transition. Please note that these may not be the final versions of the codes and
that will not be accepted for billing or payment purposes until the October 1, 2015
implementation date.
ICD-9 Codes
426.0
Atrioventricular block, complete
426.10 - Atrioventricular block, other and unspecified
426.13
426.2
Left bundle branch hemiblock
426.3
Other left bundle branch block
426.4
Right bundle branch block
426.50 - Bundle branch block, other and unspecified
426.54
426.6
Other heart block
426.7
Anomalous atrioventricular excitation
426.81 Other specified conduction disorders
426.89 Other specified conduction disorders
426.9
Conduction disorder, unspecified
427.0
Paroxysmal supraventricular tachycardia
427.31 Atrial fibrillation
427.32 Atrial flutter
427.61 Supraventricular premature beats
427.81 Sinoatrial node dysfunction
780.2
Syncope and collapse
ICD-10 Codes
I44.0- I44.7
I45.0-I45.9
I47.1
I48.0-I48.9
I49.1
I49.5
R55
Atrioventricular and left bundle-branch block
Other conduction disorders
Supraventricular tachycardia
Atrial fibrillation and flutter
Atrial premature depolarization
Sick sinus syndrome
Syncope and collapse
Mobile Outpatient Cardiac Telemetry (CardioNet) May 14
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CPT Codes
93228
93229
0295T
0296T
0297T
0298T
External mobile cardiovascular telemetry with electrocardiographic
recording, concurrent computerized real time data analysis and
greater than 24 hours of accessible ECG data storage (retrievable
with query) with ECG triggered and patient selected events
transmitted to a remote attended surveillance center for up to 30
days; review and interpretation with report by a physician or other
qualified health care professional (revised in 2013)
External mobile cardiovascular telemetry with electrocardiographic
recording, concurrent computerized real time data analysis and
greater than 24 hours of accessible ECG data storage (retrievable
with query) with ECG triggered and patient selected events
transmitted to a remote attended surveillance center for up to 30
days; technical support for connection and patient instructions for
use, attended surveillance, analysis and physician prescribed
transmission of daily and emergent data reports as prescribed by a
physician or other qualified health care professional
External electrocardiographic recording for more than 48 hours up
to 21 days by continuous rhythm recording and storage; includes
recording, scanning, analysis with report, review and interpretation
External electrocardiographic recording for more than 48 hours up
to 21 days by continuous rhythm recording and storage; recording
(includes connection and initial recording)
External electrocardiographic recording for more than 48 hours up
to 21 days by continuous rhythm recording and storage; scanning
analysis with report
External electrocardiographic recording for more than 48 hours up
to 21 days by continuous rhythm recording and storage; review and
interpretation
HCPCS Codes
N/A
Scientific Rationale – Update May 2014
Ambulatory electrocardiography (ECG) is a noninvasive test most frequently used to
evaluate cardiac rhythm abnormalities. Several devices are currently available.
Devices can record cardiac rhythm continuously or intermittently and can be worn
externally or implanted subcutaneously. The choice of a monitoring modality
depends on the presenting symptom, symptom frequency, and degree of
suspicion of a life-threatening arrhythmia:
1.
Traditional Holter monitors store 24 to 48 hours of data and require offline
analysis after the patient returns the device. The recorders use patient-activated
event markers (annotations) specified for the time of day. The major advantages
of Holter monitoring are the ability to continuously record ECG data and the lack
of need for patient participation in the transmission of data. The short duration
of monitoring can be inadequate if symptoms are infrequent. Limitations of
Holter monitoring include frequent noncompliance with keeping a log of
symptoms and using event markers, which significantly limits the diagnostic
value of these devices. The absence of real-time data analysis can also be an
important clinical limitation of these devices.
Mobile Outpatient Cardiac Telemetry (CardioNet) May 14
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2.
Event monitors (i.e., intermittent patient- or event-activated recorders):
Continuous looping monitors are attached to the patient through chest
electrodes or a wrist band and record (save) data only when activated by the
patient. Some of these devices have automatic triggers that recognize slow, fast,
or irregular heart rates. Once activated, data are stored for a programmable
fixed amount of time before the activation (looping memory) and a period of
time after the activation. These devices are also referred to as external loop
recorders (ELRs). Event monitors are generally used for 14- to 30-day
monitoring periods. The data are transmitted trans-telephonically to a central
monitoring station and then uploaded to a personal computer for analysis.
The major advantage of these devices compared with a traditional Holter
monitor is that they are small, allow ECG monitoring for longer time periods, and
can provide nearly real-time data analysis when the patient transmits a
recording in proximity to the symptomatic event. The limitations of these devices
include the following: The patient has to be awake and coherent enough to
activate the device unless automatic activation/trigger for cardiac pauses,
tachyarrhythmias, and bradyarrhythmias are built into the monitor; in the case
of continuously worn devices, a significant percentage of patients are
noncompliant with continuous application of the device (mostly because lead
irritation/poor skin contact during exercise); and both continuous and postevent
recorders require a degree of technological sophistication to transmit the stored
data transtelephonically to the central monitoring station. The
3.
Real-time continuous attended cardiac monitoring systems represent the newest
form of external ambulatory monitors developed to combine the benefits and
overcome the limitations of Holter and standard external loop monitors (ELRs).
They are worn continuously and are similar in size to the standard ELR. They
automatically record and transmit arrhythmic event data from an ambulatory
patient to an attended monitoring station. Data can also be recorded through
patient-triggered activation. With these devices, cardiac activity is continuously
monitored by 3 chest electrodes (some systems use a chest belt with built-in
nonadhesive electrodes) that are attached to a pager-sized sensor. The sensor
transmits collected data to a portable monitor that has a built-in cell phone and
needs to be in proximity to the patient to receive signals. The monitor is
equipped with software that analyzes the rhythm data continuously and
automatically. If an arrhythmia is detected by an arrhythmia algorithm, the
monitor automatically transmits recorded data transtelephonically (by wireless
network or land phone line) to a central monitoring station for subsequent
analysis. Any patient-activated data also are transmitted. Trained staff members
at a monitoring station analyze live incoming patient data and contact the
referring physician and patient according to predetermined criteria. A built-in
cellular phone allows transmission of data from the monitor to the central station
when the patient is away from home. The key features of these devices include
continuous real-time ECG monitoring for an extended period of time (up
to 30 days) without the requirement of patient activation an transmission of
data. The data are transmitted and analyzed immediately by technicians who can
contact the patient and/or the physician if an urgent intervention is needed
The prototype of this technology is the CardioNet system (also referred to as
mobile continuous outpatient telemetry, or MCOT system). Other systems are a
Z-patch (for 14 days monitoring) or a Lifestar (for 30 day monitoring). With
these devices, cardiac activity is continuously recorded by chest electrodes that
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are attached to a pager-sized sensor. The sensor wirelessly transmits collected
data to a portable monitor that needs to be within 30 feet of the patient to
receive signals. The monitor is equipped with a computer program that analyzes
the rhythm data. If an arrhythmia is detected by an arrhythmia algorithm, the
monitor automatically transmits recorded data wirelessly via the internet or via a
land phone to a central monitoring station for subsequent analysis. Patient
activated data is also transmitted. Trained staff at the monitoring station analyze
live incoming patient data and can contact the patient's clinician if instructed to
do so according to a prespecified set of rules provided by the clinician.
4.
Implantable loop recorders (ILRs) are subcutaneously implanted arrhythmiamonitoring devices. These leadless devices record a single-lead ECG signal
through 2 electrodes within the device. The device can be triggered
automatically or by patient activation via placement of an activator over the
device. The newest generations of these devices allow remote transmission of
data and have a battery life in excess of 24 months. Although these devices
require surgical implantation, they have been shown to be extremely useful in
diagnosing serious tachyarrhythmias and bradyarrhythmias in patients with lifethreatening symptoms such as syncope.
The optimal duration of monitoring largely depends on symptom frequency. In the
evaluation of palpitations, patients who experience daily symptoms can be evaluated
with a Holter monitor. More often, palpitations are sporadic and require slightly
longer monitoring. Syncope, in contrast, typically requires significantly longer
monitoring period, and the diagnostic yield of ambulatory monitors of any sort is
extremely limited. The value of arrhythmia monitoring for syncope is both to identify
an arrhythmia as a cause for syncope and to document a syncopal event without a
corresponding arrhythmia, thus suggesting a nonarrhythmic cause.
A report of the American College of Cardiology/American Heart Association Task
Force and the European Society of Cardiology Committee Guideline for Management
of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death
make the following recommendations regarding ambulatory electrocardiography
(ECG):
Class I
1. Ambulatory ECG is indicated when there is a need to clarify the diagnosis by
detecting arrhythmias, QT interval changes, T-wave alternans (TWA), or ST
changes, to evaluate risk, or to judge therapy. (Level of Evidence: A)
2.
Event monitors are indicated when symptoms are sporadic to establish whether
or not they are caused by transient arrhythmias. (Level of Evidence: B)
3.
Implantable recorders are useful in patients with sporadic symptoms suspected
to be related to arrhythmias such as syncope when a symptom-rhythm
correlation cannot be established by conventional diagnostic techniques. (Level
of Evidence: B)
The guidelines note further, “The use of continuous or intermittent ambulatory
recording techniques can be very helpful in diagnosing a suspected arrhythmia,
establishing its frequency, and relating symptoms to the presence of the arrhythmia.
Silent myocardial ischemic episodes may also be detected. A 24- to 48-h continuous
Holter recording is appropriate whenever the arrhythmia is known or suspected to
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occur at least once a day. For sporadic episodes producing palpitations, dizziness, or
syncope, conventional event monitors are more appropriate because they can record
over extended periods of time.”
ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular
Arrhythmias and the Prevention of Sudden Cardiac Death report state a 24- to 48-h
continuous Holter recording is appropriate whenever the arrhythmia is known or
suspected to occur at least once a day. For sporadic episodes producing palpitations,
dizziness, or syncope, conventional event monitors are more appropriate because
they can record over extended periods of time.
Per the Heart Rhythm Society (HRS) document on “Technologies for Arrhythmia
Diagnosis/Management”,
“The EKG and Holter monitors can diagnosis asymptomatic arrhythmias and give
information on the initiation/transition/termination of arrhythmias but are limited
by the duration of monitoring, can miss intermittent arrhythmias, and do not give
information of the burden of arrhythmia over an extended time. Event recorders
are generally limited to symptomatic episodes but miss asymptomatic episodes, do
not provide information about the initiation/transition/termination of arrhythmias,
give very limited information of burden of arrhythmias, and usually are of very
limited use in syncope because an unconscious patient cannot place the monitor on
the chest to make the recording. External and insertable looping recorders are
more long-term in monitoring that can allow better diagnosis of intermittent
arrhythmias including syncope if activated but due to the limitations of memory and
appropriate activation, can miss asymptomatic arrhythmias, and crucial information
about initiation/transition/termination of arrhythmias. External loop recorders give
limited information on longitudinal burden and rates during arrhythmia.”
The HRS report that Mobile cardiac outpatient telemetry (MCOT) and continuous
long-term monitoring are also approved technologies and can fill important gaps in
arrhythmia diagnosis noted above. Both of these long-term continuous monitors not
only have the ability to document burden, symptoms and correlate them to the
entire rhythm episode, but also have the added ability to record and analyze
asymptomatic arrhythmias. HRS reports these technologies can be particularly
important in the setting of diagnosing patients with atrial fibrillation, cryptogenic
stroke and after atrial fibrillation ablation.
Per the HRS document, “Non-invasive continuous monitors (MCOT or long-term
continuous monitors) fill a very important role in arrhythmia diagnosis and
management. They have specific utility in diagnosing asymptomatic arrhythmias as
well as intermittent arrhythmias that do not happen daily or are difficult to capture
with an event recorder due to loss of consciousness or the duration of
arrhythmia. Utilization of these technologies has demonstrated appreciable impact
on patient care and should be recognized and reimbursed appropriately.”
2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical
Ablation of Atrial Fibrillation: Recommendations for Patient Selection, Procedural
Techniques, Patient Management and Follow-up, Definitions, Endpoints, and
Research Trial Design” report:
“Arrhythmia monitoring can be performed with the use of noncontinuous or
continuous ECG monitoring tools. Choice of either method depends on individual
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need and consequence of arrhythmia detection. Basically, more intensive
monitoring is associated with a greater likelihood of detecting both symptomatic
and asymptomatic AF. They state further in the guidelines that a four-week
autotrigger event monitor, mobile cardiac outpatient telemetry system, or
implantable subcutaneous monitor may identify less frequent AF.
de Asmundis et al (2014) compared the diagnostic value of Holter ECG and a
patient-activated event recorder (OMRON portable HeartScan ECG Monitor)
(HeartScan) in the detection of arrhythmias in patients with paroxysmal palpitations
or dizziness suggestive of cardiac arrhythmias. Patients with paroxysmal
palpitations or dizziness were eligible for this study. All patients underwent an HM
for 24 h and a 15-day HeartScan after the HM. Six hundred and twenty-five
patients (48% male, mean age: 37 ± 11 years) were included in the study. All
patients present with normal heart structure, normal baseline 12-lead ECG, and
normal echocardiogram. Indications for ECG monitoring were palpitations in 577
patients (92.3%) and dizziness in 48 (7.7%). Holter monitoring offered a clinical
diagnosis in 11 patients (1.8%). Conversely, HeartScan diagnosed the clinical
arrhythmia in 558 individuals (89%). Detection of symptoms-related arrhythmias
by means of HeartScan was significantly higher when compared with HM (P <
0.01).Investigators concluded the studied system proved to be an efficient event
recorder providing the diagnosis of the clinical arrhythmia in 89% of patients with
paroxysmal palpitations or dizziness. Further studies are needed to confirm these
results.
Tsang and Mohan (2013) sought to establish if a patient monitored with mobile
cardiac telemetry (MCOT) sees different outcomes regarding diagnostic yield of
arrhythmia, therapeutic management through the use of antiarrhythmic drugs, and
cardiovascular costs incurred in the hospital setting when compared with more
traditional monitoring devices, such as the Holter or the Event monitor. The
authors conducted a retrospective analysis spanning 57 months of claims data from
January 2007 to September 2011 pertaining to 200,000+ patients, of whom 14,000
used MCT only, 54,000 an Event monitor only, and 163,000 a Holter monitor only.
Those claims came from the Truven database, an employer database that counts
2.8 million cardiovascular patients from an insured population of about 10 million
members. The authors employed a pair-wise pre/post test-control methodology,
and ensured that control patients were similar to test patients along the following
dimensions: age, geographic location, type of cardiovascular diagnosis both in the
inpatient and outpatient settings, and the cardiovascular drug class the patient
uses. The diagnostic yield of patients monitored with MCT is 61%, that is
significantly higher than that of patients that use the Event monitor (23%) or the
Holter monitor (24%). Patients naive to antiarrhythmic drugs initiate drug therapy
after monitoring at the following rates: 61% for patients that use MCOT compared
with 39% for patients that use the Event and 43% for patients that use the Holter.
Ziopatch
Peer review published literature assessing the safety and/or impact on health
outcomes for the Zio Patch for long-term cardiac rhythm monitoring is very limited.
Barrett et al (2014) evaluated 146 patients referred for evaluation of cardiac
arrhythmia whom underwent simultaneous ambulatory ECG recording with a
conventional 24-hour Holter monitor and a 14-day adhesive patch monitor. The
primary outcome of the study was to compare the detection arrhythmia events over
total wear time for both devices. Arrhythmia events were defined as detection of any
Mobile Outpatient Cardiac Telemetry (CardioNet) May 14
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1 of 6 arrhythmias, including supraventricular tachycardia, atrial fibrillation/flutter,
pause greater than 3 seconds, atrioventricular block, ventricular tachycardia, or
polymorphic ventricular tachycardia/ventricular fibrillation. McNemar's tests were
used to compare the matched pairs of data from the Holter and the adhesive patch
monitor. Over the total wear time of both devices, the adhesive patch monitor
detected 96 arrhythmia events compared with 61 arrhythmia events by the Holter
monitor (P < .001). Investigators concluded the adhesive patch monitor detected
more events than the Holter monitor. Prolonged duration monitoring for detection of
arrhythmia events using single-lead, less-obtrusive, adhesive-patch monitoring
platforms could replace conventional Holter monitoring in patients referred for
ambulatory ECG monitoring.
Schreiber et al (2014) described the use of a novel device applied at emergency
department (ED) discharge that provides continuous prolonged cardiac monitoring.
The authors enrolled discharged adult ED patients with symptoms of possible cardiac
arrhythmia. A novel, single use continuous recording patch (ZioPatch) was applied at
ED discharge. Patients wore the device for up to 14 days or until they had symptoms
to trigger an event. They then returned the device by mail for interpretation.
Significant arrhythmias are defined as: ventricular tachycardia (VT) ≥4 beats,
supraventricular tachycardia (SVT) ≥4 beats, atrial fibrillation, ≥3 second pause, 2nd
degree Mobitz II, 3rd degree AV Block, or symptomatic bradycardia.
There were 174 patients were enrolled and all mailed back their devices. The
average age was 52.2 (± 21.0) years, and 55% were female. The most common
indications for device placement were palpitations 44.8%, syncope 24.1% and
dizziness 6.3%. Eighty-three patients (47.7%) had ≥1 arrhythmias and 17 (9.8%)
were symptomatic at the time of their arrhythmia. Median time to first arrhythmia
was 1.0 days (IQR 0.2-2.8) and median time to first symptomatic arrhythmia was
1.5 days (IQR 0.4-6.7). 93 (53.4%) of symptomatic patients did not have any
arrhythmia during their triggered events. The overall diagnostic yield was 63.2%
The authors concluded the ZioPatch cardiac monitoring device can efficiently
characterize symptomatic patients without significant arrhythmia and has a higher
diagnostic yield for arrhythmias than traditional 24-48 hour Holter monitoring. It
allows for longer term monitoring up to 14 days.
There is no mention of the Zio Patch on the sites of the American College of
Cardiology or the American Heart Association. Centers for Medicare and Medicaid
Services NCD for Electrocardiographic Services does not mention Ziopatch in their
policy.
Scientific Rationale – Update July 2013
Peer review published literature evaluating Zio Patch continues to be very limited.
Turakhia et al (2013) evaluated compliance, analyzable signal time, interval to
arrhythmia detection, and diagnostic yield of the Zio Patch, in 26,751 consecutive
patients. The mean wear time was 7.6 ± 3.6 days, and the median analyzable time
was 99% of the total wear time. Among the patients with detected arrhythmias
(60.3% of all patients), 29.9% had their first arrhythmia and 51.1% had their first
symptom-triggered arrhythmia occur after the initial 48-hour period. Compared with
the first 48 hours of monitoring, the overall diagnostic yield was greater when data
from the entire Zio Patch wear duration were included for any arrhythmia (62.2% vs
43.9%, p <0.0001) and for any symptomatic arrhythmia (9.7% vs 4.4%, p
<0.0001). For paroxysmal atrial fibrillation (AF), the mean interval to the first
detection of AF was inversely proportional to the total AF burden, with an increasing
proportion occurring after 48 hours (11.2%, 10.5%, 20.8%, and 38.0% for an AF
Mobile Outpatient Cardiac Telemetry (CardioNet) May 14
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burden of 51% to 75%, 26% to 50%, 1% to 25%, and <1%, respectively).
Investigators concluded extended monitoring with the Zio Patch for ≤14 days is
feasible, with high patient compliance, a high analyzable signal time, and an
incremental diagnostic yield beyond 48 hours for all arrhythmia types. These findings
could have significant implications for device selection, monitoring duration, and care
pathways for arrhythmia evaluation and AF surveillance.
Rosenberg et al (2013) compared the Zio Patch, with a 24-hour Holter monitor in 74
consecutive patients with paroxysmal AF referred for Holter monitoring for detection
of arrhythmias. The Zio Patch was well tolerated, with a mean monitoring period of
10.8 ± 2.8 days (range 4-14 days). Over a 24-hour period, there was excellent
agreement between the Zio Patch and Holter for identifying AF events and estimating
AF burden. Although there was no difference in AF burden estimated by the Zio Patch
and the Holter monitor, AF events were identified in 18 additional individuals, and
the documented pattern of AF (persistent or paroxysmal) changed in 21 patients
after Zio Patch monitoring. Other clinically relevant cardiac events recorded on the
Zio Patch after the first 24 hours of monitoring, including symptomatic ventricular
pauses, prompted referrals for pacemaker placement or changes in medications. As a
result of the findings from the Zio Patch, 28.4% of patients had a change in their
clinical management. Investigators concluded the Zio Patch was well tolerated, and
allowed significantly longer continuous monitoring than a Holter, resulting in an
improvement in clinical accuracy, the detection of potentially malignant arrhythmias,
and a meaningful change in clinical management. Further studies are necessary to
examine the long-term impact of the use of the Zio Patch in AF management.
In a pilot study, Kamel et al (2013) randomly assigned 40 patients with cryptogenic
ischemic stroke or high-risk transient ischemic attack to wear a Cardionet mobile
cardiac outpatient telemetry monitor for 21 days or to receive routine follow-up
alone. After thorough investigation, they excluded patients with documented AF or
other apparent stroke pathogenesis. They contacted patients and their physicians at
3 months and at 1 year to ascertain any diagnoses of AF or recurrent stroke or
transient ischemic attack. The baseline characteristics of our cohort broadly
matched those of previous observational studies of monitoring after stroke. In the
monitoring group, patients wore monitors for 64% of the assigned days, and 25% of
patients were not compliant at all with monitoring. No patient in either study arm
received a diagnosis of AF. Cardiac monitoring revealed AF in zero patients (0%;
95% confidence interval, 0%-17%), brief episodes of atrial tachycardia in 2 patients
(10%; 95% confidence interval, 1%-32%), and nonsustained ventricular tachycardia
in 2 patients (10%; 95% confidence interval, 1%-32%). Investigators concluded
the rate of AF detection was lower than expected, incidental arrhythmias were
frequent, and compliance with monitoring was suboptimal. Their findings highlight
the challenges of prospectively identifying stroke patients at risk for harboring
paroxysmal AF and ensuring adequate compliance with cardiac monitoring. Clinical
Trial Identifier: NCT00715533.
Miller et al (2013) performed a retrospective analysis on patients evaluated by MCOT
monitoring within 6 months of a cryptogenic stroke or TIA. Multivariate analysis with
survival regression methods was performed using baseline characteristics to
determine predictive risk factors for detection of PAF. Kaplan-Meier estimates were
computed for 21-day PAF rates. 156 records were analyzed. paroxysmal atrial
fibrillation (PAF) occurred in 27 of 156 (17.3%) patients during MCOT monitoring of
up to 30 days. The rate of PAF detection significantly increased from 3.9% in the
initial 48 h, to 9.2% at 7 days, 15.1% at 14 days, and 19.5% by 21 days (p<0.05).
Mobile Outpatient Cardiac Telemetry (CardioNet) May 14
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Female gender, premature atrial complex on ECG, increased left atrial diameter,
reduced left ventricular ejection fraction and greater stroke severity were
independent predictors of PAF detection on multivariate analysis with strongest
correlation seen for premature atrial complex on ECG (HR 13.7, p=0.001).
Reviewers concluded MCOT frequently detects PAF in patients with cryptogenic
stroke and TIA. Length of monitoring is strongly associated with detection of PAF,
with an optimal monitoring period of at least 21 days. Of the predictors of PAF
detection, the presence of premature atrial complexes on ECG held the strongest
correlation with PAF.
Scientific Rationale – Update July 2012
The Holter Monitor has been the gold standard for detecting heart arrhythmias and
rhythm monitoring since the early 1960s.
The Zio Patch, manufactured by iRhythym, is being proposed as a long-term
cardiac rhythm monitor that provides continuous monitoring for up to 14 days. By
providing a longer time period of continuous recording, the Zio Patch is proposed to
improve the likelihood of capturing arrhythmias and provide for an equal or higher
diagnostic yield versus other devices on the market. The Zio Patch is indicated for
use on patients who may be asymptomatic or who may suffer from transient
symptoms such as palpitations, dizziness, light-headedness, pre-syncope and
syncope, shortness of breath, anxiety and fatigue.
Zio Patch received 510(k) Premarket Notification from the U.S. FDA on February 6,
2012. The Device Classification Name is 'Recorder, magnetic tape, medical'. The
510(K) number is K113862. The FDA notes indications for use: "The Zio Patch is a
prescription only single patient use, continuous recording EGG monitor that can be
worn for up to 14 days. It is indicated for use on patients who experience transient
symptoms such as syncope, palpitations, shortness of breath, or chest pains".
Higgens et al. (2012) Scripps Memorial Hospital La Jolla was the only hospital in
Southern California to participate in a study on the Zio Patch. Other study locations
included Stanford Hospital and Scott & White Memorial Hospital in Temple, Texas.
The study followed 285 patients who had presented to EDs across the country with
symptoms possibly related to arrhythmias, such as fainting, palpitations, dizziness
and others. Patients received the wire-free Zio Patch prior to being discharged from
the emergency room and were instructed to wear the patch until it no longer
adhered to their skin, up to 14 days duration. Devices were mailed back to iRhythm
Technologies, Inc., for analysis and reporting of results to the patient's physician.
The researchers found that 59 percent of the symptomatic patients who presented
to the ERs did not have arrhythmia and may not require any further work-up.
"Thus, the new device has the potential to save the health care system money."
There is currently an ongoing Clinical Trial sponsored by iRhythm Technologies, Inc.
titled: "True Continuous ECG Monitoring (TCEM Study)" with the ClinicalTrials.gov
Identifier of NCT01559246. This was started on March 9, 2012 and the estimated
study completion date is August 2012. The purpose of this study is to compare
short-term (up to 48 hours) traditional cardiac rhythm monitoring using a standard
ambulatory Holter monitor versus long-term (up to 14 days), continuous
ambulatory cardiac rhythm monitoring using Zio Patch. The study is currently
enrolling about 150 Scripps adult patients who have been seen by their doctors for
arrhythmia. Dr. Topol et al. from Scripps Memorial Hospital will compare the data
gathered from each device and report their findings later this year.
Mobile Outpatient Cardiac Telemetry (CardioNet) May 14
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Sattar et al. (2011) Between Feb-Oct., 2011, the Zio Patch was initiated on a
sample of ED patients with suspected arrhythmias (ARR) upon discharge. Patients
could wear the Zio Patch for up to 14 days and press the integrated marker button
when symptomatic. Devices were mailed back for analysis for any significant ARR
defined as: ventricular tachycardia (VT), paroxysmal atrial fibrillation (PAF),
supraventricular tachycardia (SVT), >=3 sec pause, 2nd degree Mobitz II or 3rd
degree AV Block, or symptomatic bradycardia. Descriptive statistics were used for
analysis. 135 patients, 65 males (48%), mean age 48.6 (SD 21.3), were enrolled
and none were lost to follow-up. Palpitations (30%) or syncope (18%) were the
most common indications. Average device wear time was 6.1 days (SD 3.1; max 14
days). 51 (38%) had >=1 significant ARR and 7 were symptomatic at the time.
Average time to first ARR episode was 1.8 days (SD 2.2; max 9.8 days) and first
symptomatic ARR 2.1 days (SD 3.0; max 8.6 days). 44 SVT, 5 PAF, 3 VT, and 1 AV
Block were detected. 81 symptomatic patients (60%) did not have any significant
ARR. Conclusions: The prevalence of ARR in discharged ED patients (38%) is
significant. Many symptomatic patients (60%) are found to not have ARR. Our data
suggests that a minimum of 7 days of ambulatory cardiac monitoring is required to
optimize detection in most ED patients. Use of the Zio Patch in the ED may facilitate
arrhythmia diagnosis and potentially save healthcare costs. However, this is a very
new device and additional peer-reviewed and comparative trials with holter
monitors are necessary to determine if the Zio Patch is superior to other available
approaches.
Mittal et al. (2011) notes that "Clinical experience with the Zio Patch is currently
lacking." The author stated that it is not known how well patients can tolerate the
patch for one to two weeks, and whether the patch can yield a high-quality artifactfree ECG recording through the entire recording period. The authors state,
furthermore, that "The clinical implications of not having access to ECG information
within the recording period need to be determined."
The Center for Medicare and Medicaid Services (CMS):
No National Coverage Determination (NCD) was identified on the CMS
website for the Zio Patch or for cardiac monitoring. However, two technology
assessment reports were located for ECG-based signal analysis within the
CMS coverage database:

ECG-based Signal Analysis Technologies: An enhanced ECG-based test
might demonstrate greater positive or negative predictive values,
thereby limiting the harms associated with delays in treatment, or
providing the diagnostic information necessary to avoid invasive
diagnostic or therapeutic interventions. The Coverage and Analysis
Group at the Centers for Medicare and Medicaid Services (CMS)
requested this report from The Technology Assessment Program (TAP)
at the Agency for Healthcare Research and Quality (AHRQ).

Systematic Review of ECG-based Signal Analysis Technologies for
Evaluating Patients With Acute Coronary Syndrome: The Coverage and
Analysis Group at the Centers for Medicare and Medicaid Services
(CMS) requested this report from the Technology Assessment Program
(TAP) at the Agency for Healthcare Research and Quality (AHRQ). The
purpose of this technology assessment is to summarize the clinical and
scientific evidence for commercially available ECG-based signal
Mobile Outpatient Cardiac Telemetry (CardioNet) May 14
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analysis technologies used to evaluate patients with chest pain or
other symptoms suggestive of ACS among patients at low to
intermediate risk for CAD.

CMS notes that it may create new ambulatory electrocardiographic
monitoring device categories "if published, peer-reviewed clinical
studies demonstrate evidence of improved clinical utility, or equal
utility with additional advantage to the patient, as indicated by
improved patient management and/or improved health outcomes in
the Medicare population (such as superior ability to detect serious or
life-threatening arrhythmias) as compared to devices or services
currently used."
There is no mention of the Zio Patch on the sites of the American College of
Cardiology or the American Heart Association.
In summary, the Zio Patch is a relatively new device that is being proposed as a
long-term cardiac rhythm monitor that provides continuous monitoring for up to 14
days. The most recent FDA approval of Zio Patch was on February 6, 2012.
Although studies are currently being done, additional, larger, peer-reviewed and
comparative studies with devices currently being used to assess cardiac
arrhythmias are necessary to determine if Zio Patch is equal to or superior in
clinical outcomes. At this time, it would be considered investigational.
Scientific Rationale – Update June 2009
Rothman, 2007 reports a 17 center, randomized controlled clinical study that
compared the CardioNet mobile cardiac outpatient telemetry system (MCOT) to
patient activated loop event monitoring (LOOP). Subjects with symptoms of
syncope, presyncope, or severe palpitations who had a non-diagnostic 24-hour
Holter monitor were randomized. The primary endpoint was the confirmation or
exclusion of a probable arrhythmic cause of their symptoms. A total of 266 patients
who completed the monitoring period were analyzed. A diagnosis was made in 88%
of MCOT subjects compared with 75% of LOOP subjects (P = 0.008). In a subgroup
of patients presenting with syncope or presyncope, a diagnosis was made in 89% of
MCOT subjects versus 69% of LOOP subjects (P = 0.008). During monitoring,
clinically significant arrhythmias were detected in 41% of patients in the MCOT group
versus 14% patients using the loop monitor. This was a statistically significant
difference. For patients with syncope or presyncope, clinically significant arrhythmias
were detected in 52% of MCOT patients and in 15% of patients with loop recorders.
The authors determined that MCOT was superior in confirming the diagnosis of
clinical significant arrhythmias than the LOOP monitors.
Olson 2007 reported on a retrospective medical record review of 122 consecutive
patients evaluated using MCOT for palpitations, presyncope/syncope, or to monitor
the efficacy of a specific antiarrhythmic therapy. Seventy six of the 122 patients had
syncope, 17 experienced presyncope. Fifty eight patients had arryhmias that were
previously diagnosed. MCOT detected arrythmias in 35 patients who were not
previously diagnosed and didn’t detect arrythmias in 5 symptomatc patients.
Ten of 17 patients (59%) studied for presyncope/syncope had a diagnosis made with
MCOT. Eight of these 17 patients had a previous negative evaluation for
presyncope/syncope and five had an event correlated with the heart rhythm during
the monitoring period. Nineteen patients monitored for palpitations or
presyncope/syncope were asymptomatic during monitoring but had a prespecified
Mobile Outpatient Cardiac Telemetry (CardioNet) May 14
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arrhythmia detected. When MCOT was used as the first ambulatory monitoring
system to evaluate palpitations (n = 18), 73% of patients correlated their symptoms
with the underlying cardiac rhythm. Seven of 21 patients monitored for medication
titration had dosage adjustments during monitoring. The authors concluded that
MCOT can detect asymptomatic clinically significant arrhythmias, and was especially
useful to identify the cause of presyncope/syncope, even in patients with a previous
negative workup. MCOT system allows patients to undergo daily medication dose
titration in the outpatient setting, thus avoiding hospitalization.
A systematic evidence review of remote cardiac monitoring prepared for the Agency
for Healthcare Research and Quality by the ECRI Evidence-based Practice Center
(AHRQ, 2007) reached the following conclusions about the evidence for MCT: "This
study [by Rothman, et al., 2007] was a high-quality multicenter study with few
limitations. Therefore, the evidence is sufficient to conclude that real-time continuous
attended monitoring leads to change in disease management in significantly more
patients than do certain ELRs [external loop recorders]. However, because this is a
single multicenter study, the strength of evidence supporting this conclusion is weak.
Also, the conclusion may not be applicable to ELRs with automatic event activation,
as this model was underrepresented in the RCT [by Rothman, et al., 2007] (only
16% of patients used this model)."
In addition to Cardionet, LifeStar ACT Ambulatory Cardiac Telemetry monitoring
system in which the ECG signals are transmitted from the sensor to the handheld
monitor which is equipped with a dual memory loop configuration, both running in
parallel. One loop is auto-triggered, with programmable thresholds that starts
recording based on specific rhythms and arrhythmias detected or manually
activated by the patient. The second, and longer, recording loop is controlled
remotely to provide the physician with more information, when requested by the
monitoring center. The monitor automatically transmits the recorded ECG, via
cellular link, to the monitoring center
Another FDA-cleared device with some similarities is the HEARTLink II Monitor. This
system consist of an 11-ounce, battery operated unit which is worn by the patient
with sensors affixed to his/her chest. Heartbeat data is continuously relayed by
wireless transmission to a data processor/phone-connected station in the patient's
home. Unlike the two previous described systems, this one cannot transmit signals
to a monitoring center if the patient is outside the range of a base station in their
home.
Scientific Rationale Update - October 2008
There is currently an ongoing Clinical Trial, with the identifier number of
NCT00295204, regarding the evaluation of a mobile outpatient cardiac telemetry
system versus the standard loop event monitor. The purpose is to compare the
arrhythmia diagnostic yield of MCOT as compared to standard loop event monitors
in patients presenting with palpitations, syncope or near syncope occurring less
frequently than every 24 hours. Patients are randomized and are enrolled for 30
days. Prior testing of 24 hours of non-diagnostic monitoring is required.
(2007) The Centers for Medicare & Medicaid Services (CMS) requested that the
Agency for Healthcare Research and Quality (AHRQ) commission an evidence report
to evaluate remote cardiac monitoring devices. Remote cardiac monitoring
technologies allow home electrocardiographic (ECG) monitoring of patients with
suspected cardiac arrhythmias or at risk for developing arrhythmias. This report
Mobile Outpatient Cardiac Telemetry (CardioNet) May 14
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notes a 2006 American College of Cardiology/American Heart Association/European
Society of Cardiology (ACC/AHA/ESC) guideline on management of patients with
ventricular arrhythmias states that continuous 24-48 hour Holter recordings are
deemed appropriate when arrhythmias are known or suspected to occur at least once
a day. Because intermittent event monitors can record over longer time periods, they
are considered more appropriate when sporadic episodes produce symptoms of
syncope, dizziness, or palpitations. A clinical competence statement published by the
American College of Cardiology and the American Heart Association suggests that the
frequency of symptoms should dictate the type of recording device used. Continuous
recording devices are indicated for use in patients with frequent symptoms (at least
once a day) that may be arrhythmia-related, for patients with syncope or near
syncope, and for patients with recurrent unexplained palpitations. Continuous
monitoring is also indicated for patients receiving anti-arrhythmic therapy to assess
drug response, to monitor the rate of atrial fibrillation, and to exclude proarrythmia.
Scientific Rationale – Initial
MCOT, referred to as real-time, outpatient cardiac monitoring, is an automatically
activated system that requires no patient intervention to either capture or transmit
an arrhythmia when it occurs. When the EKG violates certain pre-selected
arrhythmia thresholds, a small telemetry transmitter utilizes the standard
telephone line, a computer modem or wireless communications and automatically
sends the ECG waveform to the receiving center where real-time analysis occurs.
The patient's physician is made aware of the EKG abnormalities based on the
notification criteria. This rapid arrhythmia recognition and physician notification is
thought to allow timely intervention. For example, the CardioNet device also has an
extended memory characteristic of digital Holter monitors; the CardioNet device is
capable of storing up to 72 hours of EKG waveforms. The physician receives both
urgent and daily reports with an analysis and report of 24 hours of monitoring each
day, similar to Holter studies. The Cardionet device’s extended memory allows the
physician to examine any portion of the ECG waveform over an entire day. This
extended memory ensures that it does not fill with EKG artifact (false positives)
where the CardioNet’s automated ECG trigger is unable to reliably discriminate
between artifact and significant arrhythmias (true positives).
The CardioNet ambulatory ECG arrhythmia detector and alarm is cleared for
marketing by the FDA based on a 510(k) premarket notification due to the FDA’s
determination that the CardioNet device was substantially equivalent to devices
that were currently on the market. Thus, the manufacturer was not required to
produce the clinical effectiveness data that is necessary to support a premarket
approval application (PMA) of drugs. Safety and effectiveness, therefore, must be
decided based on review of the current literature.
Initially, there was only study reporting the results of a retrospective analysis of the
diagnostic yield of MCOT in 28 patients with syncope, dizziness, or palpitations.
Fifteen patients had previously undergone either Holter monitoring or cardiac event
monitoring, which was nondiagnostic; of these, 6 patients were found by MCOT to
have significant cardiac arrhythmias that were not detected by previous monitoring.
In April 2005, Joshi et al published their paper reporting the data collected from
one hundred consecutive patents which were retrospectively reviewed by an
independent physician not involved in ordering the test or managing any of the
patients included in the study. Indications for MCOT monitoring included dizziness,
syncope, efficacy of drug treatment, monitoring during drug initiation, efficacy of
electrophysiological ablation, and monitor for atrial fibrillation off treatment. A
Mobile Outpatient Cardiac Telemetry (CardioNet) May 14
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clinically significant arrhythmia was detected in 51 patients, but 25 (49%) did not
have any symptoms during the arrhythmia. Interestingly, 13 of 17 patients (76%)
found to have atrial flutter/fibrillation had no symptoms during the arrhythmia.
Thirty patients had been previously monitored by either a Holter monitor or an
event recorder. In 16 of these patients, MCOT detected an arrhythmia not found by
previous monitoring. Seven patients had paroxysmal supraventricular tachycardia,
5 of whom required drug treatment. Three of the 16 patients had evidence of sinus
node disease requiring a permanent pacemaker insertion, 2 patients had evidence
of second-degree heart block requiring a change in management, and one patient
was found to have sustained ventricular tachycardia for which an cardioverterdefibrillator was implanted.
Compared with Holter monitoring and external loop recorders, MCOT increases the
sensitivity of detecting arrhythmias by providing a longer period of monitoring with
automatic detection without the need for patient activation.
Review History
July 13, 2004
March 22, 2005
July 26, 2005
April 2007
October 2008
June 2009
April 2011
March 2012
July 2012
July 2013
May 2014
Medical Advisory Council Initial approval
Updated – no change in policy
Revised to include commercial members
Update – no changes
Update – No revisions. Coding reviewed. HCPCS codes added.
Added local Medicare Criteria reference, new CPT Codes and
updated the Scientific Rationale
Update. Added Medicare Table with links to NCD, LCD and
articles. No revisions. Codes updated.
Update – no revisions
Update. Added Zio Patch as investigational.
Update – no revisions. Code Updates
Update - Revised #2, removed requirement of halter monitor
prior to MCOT when symptoms occur infrequently (less
frequently than daily); Revised #3 – removed requirement of
continuous loop monitor for 30 days prior to MCOT, when the
episodes do not last long enough to activate the monitor reliably;
or the individual is unable to manage the technical requirements
of a standard loop recorder
This policy is based on the following evidence-based guidelines:
1.
2.
3.
4.
5.
ACC/AHA Guidelines for Ambulatory Electrocardiography--Part IV. Assessment
of Symptoms that May Be Related to Disturbances of Heart Rhythm. JACC 1999
34(3) 912-48.
Agency for Healthcare Research and Quality (AHRQ). Remote cardiac monitoring.
Technology Assessment. Prepared for the AHRQ by the ECRI Evidence-based
Practice Center (EPC). Contract No. 290-02-0019. AHRQ; December 12, 2007.
Available at:
http://www.cms.hhs.gov/determinationprocess/downloads/id51TA.pdf
Hayes. Health Technology Brief. Mobile Cardiac Outpatient Telemetry (MCOT) for
Home Monitoring of Cardiac Patients. April 21, 2008. Update October 2013
Hayes. Search & Summary. Zio Patch. (iRhythm Technologies Inc. and St. Jude
Medical Inc.) Long-Term Cardiac Rhythm Monitor. May 2012. Updated April 2013
Heart Rhythm Society. Technologies for Arrhythmia Diagnosis/Management.
Available at: www.hrsonline.org/.../MCOT%20statement%20fin
Mobile Outpatient Cardiac Telemetry (CardioNet) May 14
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6.
7.
Calkins H, Kulk K, Cappato R, et al. 2012 HRS/EHRA/ECAS Expert Consensus
Statement on Catheter and Surgical Ablation of Atrial Fibrillation:
Recommendations for Patient Selection, Procedural Techniques, Patient
Management and Follow-up, Definitions, Endpoints, and Research Trial Design.
Available at: http://www.hrsonline.org/Practice-Guidance/Clinical-GuidelinesDocuments?SearchText=&seeall=1#axzz2tKYbaUCz
European Heart Rhythm Association; Heart Rhythm Society, Zipes DP, et al.
ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular
Arrhythmias and the Prevention of Sudden Cardiac Death : a report of the
American College of Cardiology/American Heart Association Task Force and the
European Society of Cardiology Committee for Practice Guidelines (Writing
Committee to Develop Guidelines for Management of Patients With Ventricular
Arrhythmias and the Prevention of Sudden Cardiac Death). J Am Coll Cardiol.
2006 Sep 5;48(5):e247-346. Available at:
http://content.onlinejacc.org/article.aspx?articleid=1137887
References – Update May 2014
1.
2.
3.
4.
5.
6.
7.
Barrett PM, Komatireddy R, Haaser S, et al. Comparison of 24-hour Holter
monitoring with 14-day novel adhesive patch electrocardiographic monitoring.
Am J Med. 2014 Jan;127(1):95.e11-7.
de Asmundis C, Conte G, Sieira J, et al. Comparison of the patientactivated event recording system vs. traditional 24 h Holter electrocardiography
in individuals with paroxysmal palpitations or dizziness. Europace. 2014 Feb 26.
Higgins SL. A novel patch for heart rhythm monitoring: is the Holter monitor
obsolete? Future Cardiol. 2013 May;9(3):325-33.
Lobodzinski SS. ECG patch monitors for assessment of cardiac rhythm
abnormalities. Prog Cardiovasc Dis. 2013 Sep-Oct;56(2):224-9.
Schreiber D, Sattar A, Drigalla D, Higgins S. Ambulatory cardiac monitoring for
discharged emergency department patients with possible cardiac arrhythmias.
West J Emerg Med. 2014 Mar;15(2):194-8.
Tsang JP, Mohan S. Benefits of monitoring patients with mobile cardiac
telemetry (MCT) compared with the Event or Holter monitors. Med Devices
(Auckl). 2013 Dec 9;7:1-5.
Zimetbaum P, Goldman A. Ambulatory arrhythmia monitoring: choosing the
right device. Circulation. 2010 Oct 19;122(16):1629-36. Available at:
https://circ.ahajournals.org/content/122/16/1629.full.pdf
References – Update July 2013
1.
2.
3.
4.
Kamel H, Navi BB, Elijovich L, et al. Pilot randomized trial of outpatient cardiac
monitoring after cryptogenic stroke. Stroke. 2013 Feb;44(2):528-30.
Miller DJ, Khan MA, Schultz LR et al. Outpatient cardiac telemetry detects a high
rate of atrial fibrillation in cryptogenic stroke. J Neurol Sci. 2013 Jan 15;324(12):57-61.
Rosenberg MA, Samuel M, Thosani A, Zimetbaum PJ. Use of a noninvasive
continuous monitoring device in the management of atrial fibrillation: a pilot
study. Pacing Clin Electrophysiol. 2013 Mar;36(3):328-33.
Turakhia MP, Hoang DD, Zimetbaum P, et al. Diagnostic Utility of a Novel
Leadless Arrhythmia Monitoring Device. Am J Cardiol. 2013 May 11.
References – Update July 2012
Mobile Outpatient Cardiac Telemetry (CardioNet) May 14
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1.
2.
3.
4.
5.
6.
7.
8.
ClinicalTrials.gov. True Continuous ECG Monitoring (TCEM Study).
ClinicalTrials.gov Identifier: NCT01559246. Updated March 19, 2012. Available
at: http://clinicaltrials.gov/ct2/show/NCT01559246?term=Zio+patch&rank=1
Higgins H. "Prevalence of Arrhythmias in Emergency Department Patients
Discharged Using a Novel Ambulatory Cardiac Monitor. Heart Rhythm Society's
33rd Annual Scientific Sessions in Boston. May 11, 2012.
iRhythm. Zio Overview. Available at: http://www.irhythmtech.com/ziosolution/zio-patch/
Mittal S, Movsowitz C, Steinberg JS. Ambulatory external electrocardiographic
monitoring: Focus on atrial fibrillation. J Am Coll Cardiol. 2011;58(17):17411749.
Sattar A, Drigalla D, Higgins S, et al. Prevalence of arrhythmias in ED patients
discharged using a novel ambulatory cardiac monitor. Journal of the American
College of Cardiology. Conference: 61th Annual Scientific Session of the
American College of Cardiology and Summit: Innovation in Intervention, ACC.
Conference Publication: (var.pagings). (13 SUPPL. 1) (pp E642), 2012.
U.S. Food and Drug Administration (FDA). Zio Patch Model Z100. Medical
Magnetic Tape Recorder. 510(k) No. K090363. Rockville, MD: FDA; May 8, 2009.
U.S. Food and Drug Administration (FDA). K091075: Zio ECG Utilization Service
(ZEUS) System (iRhythm Technologies Inc.) cleared on July 21, 2009.
U.S. Food and Drug Administration (FDA). Zio Patch. Medical Magnetic Tape
Recorder. 510(k) No. K113862. Rockville, MD: FDA; February 6, 2012. Avilable
at: http://www.accessdata.fda.gov/cdrh_docs/pdf11/K113862.pdf
References – Update March 2012
1.
Engel JM, Chakravarthy N, Katra RP, et al. Estimation of patient compliance in
application of adherent mobile cardiac telemetry device. Conf Proc IEEE Eng
Med Biol Soc. 2011 Aug;2011:1536-9.
References – Update April 2011
1.
2.
Podrid PJ. Ambulatory monitoring in the assessment of cardiac arrhythmias.
February 7, 2011.
Kadish, AH, Reiffel, JA, Clauser, J, et al. Frequency of serious arrhythmias
detected with ambulatory cardiac telemetry. Am J Cardiol. 2010 May
1;105(9):1313-6.
References – Update June 2009
1. The diagnosis of cardiac arrhythmias: a prospective multi-center randomized
study comparing mobile cardiac outpatient telemetry versus standard loop event
monitoring. - Rothman SA - J Cardiovasc Electrophysiol - 01-MAR-2007; 18(3):
241-7
2. Utility of mobile cardiac outpatient telemetry for the diagnosis of palpitations,
presyncope, syncope, and the assessment of therapy efficacy. - Olson JA - J
Cardiovasc Electrophysiol - 01-MAY-2007; 18(5): 473-7
3. Initial experience with novel mobile cardiac outpatient telemetry for children and
adolescents with suspected arrhythmia. Saarel EV - Congenit Heart Dis - 01-JAN2008; 3(1): 33-8
References – Update October 2008
1. Clinical Trials.gov. Evaluation of a Mobile Cardiac Outpatient Telemetry System
Versus Standard Loop Event Monitor. Available at:
http://clinicaltrials.gov/ct2/show/NCT00295204
Mobile Outpatient Cardiac Telemetry (CardioNet) May 14
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2. Saarel EV, Doratotaj S, Sterba R. Initial experience with novel mobile cardiac
outpatient telemetry for children and adolescents with suspected arrhythmia.
Congenit Heart Dis. 2008;3 (1):33-38.
3. Olson JA, Fouts AM, Padanilam BJ, et al. Utility of Mobile Cardiac Outpatient
Telemetry for the Diagnosis of Palpitations, Presyncope, Syncope, and the
Assessment of Therapy Efficacy. Journal of Cardiovascular Electrophysiology.
06/25/2007.
4. Rothman SA, Laughlin JC, Seltzer J, et al. The diagnosis of cardiac arrhythmias: a
prospective multi-center randomized study comparing mobile cardiac outpatient
telemetry versus standard loop event monitoring. J Cardiovasc Electrophysiol.
2007;18(3):1-7. Available at:
http://www.cardionet.com/media/pdf/MCOTRothma.pdf.
5. Calkins H, Brugada J, Packer DL, et al. European Heart Rhythm Association
(EHRA); European Cardiac Arrhythmia Society (ECAS); American College of
Cardiology (ACC); American Heart Association (AHA); Society of Thoracic
Surgeons (STS). HRS/EHRA/ECAS expert Consensus Statement on catheter and
surgical ablation of atrial fibrillation: recommendations for personnel, policy,
procedures and follow-up. A report of the Heart Rhythm Society (HRS) Task
Force on catheter and surgical ablation of atrial fibrillation. Heart Rhythm.
2007;4(6):816-861. Available at: http://www.or-live.com/hrs/2216/HR-andEuro-AF-Consensus-Stmt.pdf.
6. Olson JA, Fouts AM, Padanilam BJ, et al. Utility of mobile cardiac outpatient
telemetry for the diagnosis of palpitations, presyncope, syncope, and the
assessment of therapy efficacy. J Cardiovasc Electrophysiol. 2007;18 (5):473477.
7. Giada F, Gulizia M, Francese M, et al. Recurrent unexplained palpitations (RUP)
study comparison of implantable loop recorder versus conventional diagnostic
strategy. J Am Coll Cardiol. 2007;49 (19): 1951-1956.
8. Highmark Local Medicare Services. LCD M-60D - Real-Time, Outpatient Cardiac
Monitoring. Available at:
http://www.highmarkmedicareservices.com/policy/partb/m1/m60d.html
References – Initial
1. Joshi AK, Kowey PR, Prystowsky EN, et al. First experience with a Mobile Cardiac
Outpatient Telemetry (MCOT) system for the diagnosis and management of
cardiac arrhythmia. Am J Cardiol. 2005 Apr 1;95(7):878-81.
2. Kowey PR, et al. First Experience with a Mobile Cardiac Outpatient Telemetry
(MCOT) System for the Diagnosis and Management of Cardiac Arrhythmia.'
NASPE Heart Rhythm Society 24th Annual Scientific Sessions. May 2003.
3. Kowey PR, Kocovic DZ. Cardiology patient page: Ambulatory
electrocardiographic recording. Circulation. 2003;108:e31-e33. Available at
http://www.circulationha.org.
4. CardioNet: Monitoring at the Speed of Life [website]. Philadelphia, PA:
CardioNet; 2003. Available at: http://www.cardionet.com.
5. Zimetbaum, PJ, Josephson ME. The evolving role of ambulatory arrhythmia
monitoring in general clinical practice. Ann Intern Med. 1999;130(10):848-856.
6. CardioNet. A new service: Mobile outpatient cardiac telemetry. Control No. 2200011-01. San Diego, CA: CardioNet; 2002. Available at:
http://www.cardionet.com/images/brochure.pdf.
7. U.S. Food and Drug Administration, Center for Devices and Radiologic Health.
CardioNet ambulatory ECG monitor with arrhythmia detection. 510(k) No.
K012241 (traditional). Rockville, MD: FDA; February 1, 2002. Available at:
http://www.fda.gov/cdrh/pdf/k012241.pdf.
Mobile Outpatient Cardiac Telemetry (CardioNet) May 14
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8. U.S. Food and Drug Administration, Center for Devices and Radiologic Health.
CardioNet Ambulatory ECG Monitor, Model CN10000A. 510(k) No. K003707
(traditional). Rockville, MD: FDA; May 16, 2001. Available at:
http://www.fda.gov/cdrh/pdf/k003707.pdf.
9. Rissam HS, Kishore S, Bhatia ML. Trehan N. Trans-telephonic
electrocardiographic monitoring--experience in India. J Telemed Telecare.
1998;4 Suppl 1:8-11.
10. Antman EM, Ludmer PL, McGowan N, et al. Transtelephonic electrocardiographic
transmission for management of cardiac arrhythmias. Am J Cardiol. 1986 Nov
1;58(10):1021-4.
11. David D, Michelson EL. Transtelephonic electrocardiographic monitoring for the
detection and treatment of cardiac arrhythmias. Cardiovasc Clin.
1988;18(3):73-82. Smith MS, Pritchett EL. Electrocardiographic monitoring in
ambulatory patients with cardiac arrhythmias. Cardiol Clin. 1983 May;1(2):293304.
Important Notice
General Purpose.
Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering
plan benefits and determining whether a particular procedure, drug, service or supply is medically
necessary. The Policies are based upon a review of the available clinical information including clinical
outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device,
evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select
national health professional organizations. Coverage determinations are made on a case-by-case basis and
are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, including
medical necessity requirements. Health Net may use the Policies to determine whether under the facts and
circumstances of a particular case, the proposed procedure, drug, service or supply is medically
necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not
constitute coverage. The member's contract defines which procedure, drug, service or supply is covered,
excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current
criteria that have been approved by Health Net’s National Medical Advisory Council (MAC). The clinical
criteria and medical policies provide guidelines for determining the medical necessity criteria for specific
procedures, equipment, and services. In order to be eligible, all services must be medically necessary and
otherwise defined in the member's benefits contract as described this " Important Notice" disclaimer. In all
cases, final benefit determinations are based on the applicable contract language. To the extent there are
any conflicts between medical policy guidelines and applicable contract language, the contract language
prevails. Medical policy is not intended to override the policy that defines the member’s benefits, nor is it
intended to dictate to providers how to practice medicine.
Policy Effective Date and Defined Terms.
The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined
by Health Net. All policies are subject to applicable legal and regulatory mandates and requirements for
prior notification. If there is a discrepancy between the policy effective date and legal mandates and
regulatory requirements, the requirements of law and regulation shall govern. * In some states, new or
revised policies require prior notice or posting on the website before a policy is deemed effective. For
information regarding the effective dates of Policies, contact your provider representative. The Policies do
not include definitions. All terms are defined by Health Net. For information regarding the definitions of
terms used in the Policies, contact your provider representative.
Policy Amendment without Notice.
Health Net reserves the right to amend the Policies without notice to providers or Members. In some
states, new or revised policies require prior notice or website posting before an amendment is deemed
effective.
No Medical Advice.
The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to
members. Members should consult with their treating physician in connection with diagnosis and
treatment decisions.
No Authorization or Guarantee of Coverage.
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The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service
or supply. Members and providers should refer to the Member contract to determine if exclusions,
limitations, and dollar caps apply to a particular procedure, drug, service or supply.
Policy Limitation: Member’s Contract Controls Coverage Determinations.
The determination of coverage for a particular procedure, drug, service or supply is not based upon the
Policies, but rather is subject to the facts of the individual clinical case, terms and conditions of the
member’s contract, and requirements of applicable laws and regulations. The contract language contains
specific terms and conditions, including pre-existing conditions, limitations, exclusions, benefit maximums,
eligibility, and other relevant terms and conditions of coverage. In the event the Member’s contract (also
known as the benefit contract, coverage document, or evidence of coverage) conflicts with the Policies,
the Member’s contract shall govern. Coverage decisions are the result of the terms and conditions of the
Member’s benefit contract. The Policies do not replace or amend the Member’s contract. If there is a
discrepancy between the Policies and the Member’s contract, the Member’s contract shall govern.
Policy Limitation: Legal and Regulatory Mandates and Requirements.
The determinations of coverage for a particular procedure, drug, service or supply is subject to applicable
legal and regulatory mandates and requirements. If there is a discrepancy between the Policies and legal
mandates and regulatory requirements, the requirements of law and regulation shall govern.
Policy Limitations: Medicare and Medicaid.
Policies specifically developed to assist Health Net in administering Medicare or Medicaid plan benefits and
determining coverage for a particular procedure, drug, service or supply for Medicare or Medicaid
members shall not be construed to apply to any other Health Net plans and members. The Policies shall
not be interpreted to limit the benefits afforded Medicare and Medicaid members by law and regulation.
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